Industry Pitch

The Generic Pharmaceutical Association (GPhA) on Dec. 15, 2011, announced a proposal it calls the Accelerated Recovery Initiative, a voluntary initiative aimed at minimizing drug shortages by enhancing communications between stakeholders in the generic drug arena. It calls for manufacturers, wholesalers, group purchasing organizations and the FDA to collaborate to provide a better understanding of current and impending drug shortages.

The Accelerated Recovery Initiative calls for an independent third party that would track supply information for products deemed critical and identify probable shortages, focusing on products where a shortage is expected to last more than 90 days. Initially the “critical” criteria would mean a focus on generic injectable products, but it could expand to other products with few manufacturing options and no substitute. It also would create a “high-level SWAT team” within the FDA, encompassing separate agency departments, to quickly respond to critical shortages. The program would be voluntary and would not address drug pricing information.

“GPhA is certainly a key player in this because the shortages tend to happen as the products become genericized, “ says James Czaban, chair of the Food & Drug Law practice at Wiley Rein. “They’re trying to work collaboratively, and it’s the sort of thing where any good and creative idea is welcome in the hopes that it might improve the situation.”

The GPhA initiative would require prior approval of the Federal Trade Commission and Department of Health and Human Services. As of December 2011, the FDA didn’t have immediate plans to implement the initiative, according to the FDA’s Valerie Jensen.